Metastatic NSCLC Clinical Trial
— CH:IIOfficial title:
Use of Chinese Herbal Formula Shu Yu Wan in Lung Cancer Patients: a Randomized Double-blind Placebo- Controlled Trial
NCT number | NCT04615884 |
Other study ID # | CH:II |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2022 |
Est. completion date | March 2024 |
Verified date | August 2022 |
Source | Lady Davis Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate whether Chinese Herb supplements lead to a measurable improvement in symptoms commonly experienced by patients with advanced stage lung cancer and an improvement in quality of life. In our previously conducted single-arm observational study we found significant improvement in physical well-being, tiredness and drowsiness with no evidence of increased toxicity even in those on cytotoxic chemotherapy. Based on the encouraging results of this study we plan to move to a placebo-controlled study using the same Chinese Herb formula.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 2024 |
Est. primary completion date | March 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Patients must meet the following criteria for study entry: - Signed informed consent - Ability to comply with protocol - Aged =18 years - Histologically or cytologically documented metastatic NSCLC (American Joint Committee on Cancer [AJCC] staging system) - Prior chemotherapy or radiotherapy is allowed provided the patient has recovered from any toxic effects - Either off chemotherapy with no plans to start within the next 8 weeks OR on first or second line systemic anti-cancer treatment for NSCLC and completed at least 1 cycle of their current treatment prior to randomization. Permitted chemotherapy regimens are: standard systemic chemotherapy, targeted therapy, immunotherapy or any combinations of the three - Karnofsky performance status of =60 - Life expectancy = 12 weeks - Adequate hematologic and end-organ function defined by the following laboratory results obtained within 14 days prior to the first study eligibility): ANC 1. 3 -3.5 x^109/L WBC counts 4.0 - 11 x^109/L Platelet count 150 - 400 x^109/L Hemoglobin 90 -150 g/dL Liver function tests AST = 1.5 x ULN / ALT = 1.5 x ULN L Serum bilirubin 3.0-17.0 x U/L INR =1.5 x ULN Creatinine clearance 50-120 mL/min Exclusion Criteria: Patients who meet any of the following criteria will be excluded from the study entry: - Active or untreated central nervous system metastases - Uncontrolled pleural effusion - Patients or families who do not speak English or French - Abnormal liver function as defined above - Taking regular anti-convulsants, Coumadin or related anti-coagulant - Taking regular immunosuppressive medications: azathioprine (Imuran), basiliximab (Simulect), cyclosporine (Neoral, Sandimmune), daclizumab (Zenapax), muromonab-CD3 (OKT3, Orthoclone OKT3), mycophenolate (CellCept), tacrolimus (FK506, Prograf), sirolimus (Rapamune), or other immunosuppressive or anti-coagulant that metabolized by liver. |
Country | Name | City | State |
---|---|---|---|
Canada | Peter Brojge Lung Cancer Center, Jewish General Hospital | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Lady Davis Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Physical Well-Being Scores at Baseline and 6 Weeks | The primary objective is to compare the change in patient reported Physical Well-Being (PWB) subscale of the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire. The Physical well-being (PWB) subscale has 7 questions with the range of the score from 0 to 4 each. The range of the total score is 0 to 28. The higher the score the better the physical well-being. | Baseline and 6 weeks | |
Secondary | Fatigue scores at Baseline and 6 weeks | The secondary objective is to compare change in Fatigue subscale on the Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) questionnaire. Symptoms and health status will be assessed using the Functional Assessment of Cancer Therapy-lung (FACT-L), and Functional Assessment for Chronic Illness Therapy - Fatigue (FACIT-F). The FACT-L is a 36-item self-report questionnaire that evaluates quality of life in lung cancer patients. Twenty-nine items measure physical, social, emotional and functional well-being; The final 7 items constitute the Lung Cancer Symptom Scale (LCSS). The FACIT-F Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). | Baseline and 6 weeks |
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